Bactisure Wound Lavage

K192349 · Next Science, LLC · FQH · Jan 23, 2020 · General Hospital

Device Facts

• Record ID: K192349
• Device Name: Bactisure Wound Lavage
• Applicant: Next Science, LLC
• Product Code: FQH · General Hospital
• Decision Date: Jan 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.

Device Story

Bactisure Wound Lavage is an aqueous irrigation solution used for wound debridement. It is designed for use in conjunction with Zimmer Pulsavac Plus or Pulsavac Plus AC jet lavage systems. The device functions via mechanical action; fluid moving across the wound surface provides hydrodynamic shear to remove debris and microorganisms. The solution is supplied in a 1000mL polypropylene container. It is intended for clinical use by healthcare providers. The solution's chemical composition (ethanol, acetic acid, sodium acetate, benzalkonium chloride) aids the mechanical irrigation process. The device benefits patients by facilitating the removal of foreign material and microorganisms from wounds, supporting the wound healing process.

Clinical Evidence

No clinical data. Performance testing includes biocompatibility (ISO 10993-1) and sterilization validation (ISO 11737-2, ISO 14937, ISO 17665-1). Toxicological risk analysis supported the composition change. Literature and risk analyses support the added contraindication for neonates/infants.

Technological Characteristics

Aqueous irrigation solution. Composition: Ethanol (100g/L), Acetic acid (59g/L), Sodium acetate (30g/L), Benzalkonium chloride (1.3g/L), Purified water. Packaging: 1000mL polypropylene container. Sterilization: Validated per ISO 11737-2, ISO 14937, and ISO 17665-1. Mechanical principle: Hydrodynamic shear via jet lavage system.

Indications for Use

Indicated for cleansing and removal of debris, including micro-organisms, from wounds. Contraindicated for use on neonates or infants (children under age 2) due to ethanol content.

Regulatory Classification

Identification

A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• Next Science Irrigation Solution (K161165)

Submission Summary (Full Text)

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January 23, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Next Science, LLC Jeanne Lee Regulatory Manager 10550 Deerwood Park Blvd., Ste. 300 Jacksonville. Florida 32256

Re: K192349

Trade/Device Name: Bactisure Wound Lavage Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FQH Dated: November 22, 2019 Received: November 26, 2019

Dear Jeanne Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Kimberly Ferlin, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K192349

Device Name Bactisure Wound Lavage

Indications for Use (Describe)

Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

× | Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# K192349 510(k) Summary

# Bactisure™ Wound Lavage

| Applicant: | Next Science™, LLC<br>10550 Deerwood Park<br>Suite 300<br>Jacksonville, FL 32256 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jeanne Lee<br>Next Science™, LLC<br>10550 Deerwood Park<br>Suite 300<br>Jacksonville, FL 32256<br>Regulatory Affairs Manager<br>1-855-564-2762 ext. 6003 |
| Date Prepared: | August 26, 2019 |
| Device Trade Name: | Bactisure™ Wound Lavage |
| Device Common Name: | Jet Lavage |
| Classification Name: | Lavage. Jet |

| Classification Name. | Lavage, Jet |
|----------------------|------------------------|
| Product Code: | FQH, FRO |
| Classification: | Class II, unclassified |
| CFR: | 21 CFR 880.5475 |

#### Predicate Device:

Next Science™ Irrigation Solution, K161165

#### Indications for Use:

Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus or Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.

#### Device Description:

Bactisure Wound Lavage is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, low-odor aqueous solution that is used to remove debris, including microorganisms, from wounds.

The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganisms, from wounds. Bactisure Wound Lavage is provided in a 1000mL polypropylene plastic container with a single port and will be labeled "not for IV use". The container will be provided in a

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polyethylene overwrap and packaged. The formulation for Bactisure Wound Lavage is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride, and water.

### Technoloqical Characteristics:

The table below summarizes any technological characteristics of Bactisure Wound Lavage as compared to the predicate device Next Science Irrigation Solution, K161165.

| | Bactisure™ Wound Lavage | Next Science™ Irrigation Solution<br>(Cleared Device K161165) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>use | Bactisure Wound Lavage is to<br>be used with the Zimmer<br>Pulsavac Plus or Pulsavac Plus<br>AC lavage systems and is<br>indicated for use in cleansing<br>and removal of debris, including<br>micro-organisms, from wounds. | Next Science Irrigation Solution is to<br>be used with a jet lavage system<br>and is indicated for use in cleansing<br>and removal of debris, including<br>microorganisms, from wounds. |
| Mechanism(s)<br>of Action | Mechanical removal of debris via hydrodynamic shear.<br>The mechanical action of moving across the wound aids in the removal<br>of foreign material such as dirt and debris. | |
| Description | Clear, colorless, low-odor solution containing ethanol, acetic acid,<br>sodium acetate and benzalkonium chloride. | |
| Composition | Ethanol, 100g/L<br>Acetic acid, 59g/L<br>Sodium acetate, 30g/L<br>Benzalkonium chloride, 1.3g/L<br>Purified water | Ethanol, 100g/L<br>Acetic acid, 50g/L<br>Sodium acetate, 30g/L<br>Benzalkonium chloride, 1.3g/L<br>Purified water |

## Performance Testing:

Biocompatibility testing meets the requirements of ISO 10993-1.

Sterilization meets the requirements of ISO 11737-2, ISO 14937 and ISO 17665-1. The addition of the contraindication "Due to the ethanol content, do not use this product on neonates or infants (children under the age of 2)" and update to the warnings within the instructions for use are supported by literature and risk analyses. Biocompatibility concerns related to the change in composition were mitigated by a toxicological risk analysis.

#### Conclusion:

The conclusions drawn from the performance tests demonstrate that the device is as safe and effective as the legally marketed device Next Science Irrigation Solution (K161165).